Omega 6:Omega 3 Ratio and Progression of Age-related Macular Degeneration (AMD).
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Purpose
Docosahexaenoic acid (DHA) supplementation has been shown to prevent specific age-related changes in the retina through biochemical and functional evaluations, but it is unclear whether increased DHA intake-reflected through elevated DHA+EPA blood levels-can affect the natural history and progression of age-related macular degeneration (AMD). AMD is a disease affecting the macula, the part of the eye containing cone photoreceptors at the center of the visual field. The macula is responsible for vision in most daily functions, including reading, seeing fine details, and colour recognition. Severe AMD can lead to a central scotoma, severely impairing daily functioning. AMD can be divided into two forms: the more severe wet AMD, consisting of proliferation of new blood vessels in the retina, and dry AMD characterized by the development of drusen, a buildup of extracellular material . The investigators are focused on the group with the highest risk of developing the two advanced forms of AMD [wet AMD or central geographic atrophy]: patients with unilateral wet AMD and dry AMD in their other eye. The study will consist of following up a cohort of such subjects and monitoring their visual function in a comprehensive manner. Working in concert with clinical ophthalmologists and basic scientists, the investigators will monitor "DHA+EPA" and "Omega6:Omega3 fatty acid ratio" levels in the blood, inherited predispositions through genetic analysis, lipofuscin (an accumulated waste product) levels & AMD progression via fundus photography, visual acuity, and retinal function via full-field and multifocal electroretinograms. These different factors will be cross-correlated and evaluated to determine how omega-3 fatty acids affect the progression of AMD.
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effect of Omega-6:Omega-3 Fatty Acid Ratio on Delaying Progression of Age-related Macular Degeneration (AMD) in Moderate to High Risk Individuals. |
- Progression of dry AMD status according to international classification/grading system. [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- Delayed progression to neovascular AMD (NVAMD) or Central Geographic Atrophy (cGA) in the fellow eye. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Whole blood for genotyping and measuring omega-3 FA status. Serum for Cytokine level analysis.
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2012 |
| Estimated Study Completion Date: | March 2017 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Men and women with Neovascular (wet) AMD in one eye and early or intermediate dry AMD in the fellow eye, taking AREDS vitamins (or equivalent).
Inclusion Criteria:
- 50+ years of age
- NVAMD (Wet) in one eye, early or intermediate dry-AMD in the fellow eye
- taking AREDS vitamins (or equivalent)
Exclusion Criteria:
- Central geographic atrophy
- Diabetic retinopathy
- Ocular surgery in the eye with dry-AMD (not including cataract IOL surgery)
- Underlying ocular pathology in the eye with dry-AMD (especially glaucoma, dense cataracts, and retinitis pigmentosa)
Contacts and Locations| Contact: Ioannis Dimopoulos, MD | 780-4929596 | dimopoul@ualberta.ca |
| Canada, Alberta | |
| Alberta Retina Consultants | Recruiting |
| Edmonton, Alberta, Canada, T5H 0X5 | |
| Contact: Matthew Tennant, MD (780) 448-1801 mtennant@ualberta.ca | |
| Royal Alexandra Hospital | Recruiting |
| Edmonton, Alberta, Canada, T5H 3V9 | |
| Contact: Ian MacDonald, MD 780-4929596 macdonal@ualberta.ca | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T6G 2H7 | |
| Contact: Ioannis Dimopoulos, MD 780-4929596 dimopoul@ualberta.ca | |
| Principal Investigator: | Yves Sauvé, PhD | Department of Ophthalmology |
More Information
Publications:
| Responsible Party: | Yves Sauve, PhD, AHFMR Senior Scholar, Ophthalmology Assistant Professor, University of Alberta, University of Alberta |
| ClinicalTrials.gov Identifier: | NCT00987129 History of Changes |
| Other Study ID Numbers: | MOP 79278, 200809MOP-192321, CIA-CBAA-27683 |
| Study First Received: | September 29, 2009 |
| Last Updated: | August 26, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Alberta:
|
DHA EPA AMD |
drusen omega-3 fatty acids omega6:omega3 ratio |
Additional relevant MeSH terms:
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013